In an August 8 letter, attached hereto, to Dr. Deyton of the Center for Tobacco Products, CRE explains in detail the reasons that the FDA peer review fails to comply with the peer review guidelines mandated by the Data Quality Act.

CRE concludes that the FDA must take the following actions to come into compliance:

1. The agency must inform the public of how it can comment on the peer review plan and must consider any public comments.

2. Unless the agency specifically determines that it is not feasible and appropriate to do so, it must revise the peer review plan to state … Continue Reading